ENS 47281

v t e ENS Event
18:14 Sep 16, 2011
Title	Agreement State Report - Medical Event Involving Y-90 Therasphere Underdose
Event Description	The following information was received from the Commonwealth of Pennsylvania via facsimile: Event Type: A medical event (ME) involving Y-90 Theraspheres where the patient received 51% of the intended dose, which is reportable under 10CFR35.3045(a)(1)(ii). 'Notifications: On September 16, 2011, at 1414 [EDT], the Department's Southeast Regional Office received notification via phone message about the ME. Event Description. The patient was being treated with MDS Nordion Y-90 glass Theraspheres for transarterial radioembolization. A suspected defective catheter caused 49% of the intended dose to clog up in the catheter. No harm to the patient is expected. The referring physician and patient have been notified. No more information is available at this time. Cause of the event: The cause of the event is suspected to be a defective catheter. Actions: After decay, the catheter will be returned to Nordion for inspection and may also be returned to the manufacturer, Terumo Medical, for a defect analysis. The licensee will be submitting a written report within 15 days. The [Pennsylvania] Department [of Environmental Protection] plans to do a reactive inspection. PA Report ID: PA110025 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

ENS 47281 +/-
Where
Thomas Jefferson University Hospital Philadelphia, Pennsylvania (NRC Region 1)
License number:	PA-0130
Organization:	Pa Bureau Of Radiation Protection
Reporting

Agreement State
Time - Person (Reporting Time:+88.22 h3.676 days <br />0.525 weeks <br />0.121 months <br />)
Opened:	Joe Melnic 10:27 Sep 20, 2011
NRC Officer:	Howie Crouch
Last Updated:	Sep 20, 2011
47281 - NRC Website
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v t e Emergency Notification System
Thomas Jefferson University Hospital with Agreement State
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